MAUDE Adverse Event Report: NALU MEDICAL, INC NALU NEUROSTIMULATION SYSTEM; PERIPHERAL NERVE STIMULATOR

Model Number	71004
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat lower back pain, around (b)(6) 2025, the patient reported no longer using the system and requested to remove it.A full system explant was performed on (b)(6) 2025 per the patient's request.
Additional Manufacturer Narrative
Review of records found two previous complaints from this patient, both were resolved by replacing external devices.The nalu personel working directly with the patient report that the area of pain was being appropriately covered by the nalu stimulator but the patient's relief was intermittent.Reprogramming was done to improve therapy and imaging was done to confirm no migration of the implanted components.There does not appear to by any system or component failure or malfunction and there are no reports of any failures or malfunctions.The patient did not report any unusual events leading up to cessation of use of the nalu system.It appears that the patient's pain symptoms were not adequately addressed with the nalu device, leading to the request for explant.It seems that the placement of the leads was appropriate based on rep statement that "coverage was always obtained".It is likely that the patient was experiencing fluctuations in pain symptoms, leading to inconsistent relief from the nalu system.The explanted device was not returned for testing, thus the firm is unable to draw any definitive conclusions regarding functionality and all assessments are formed based on personal reports from patient and nalu rep.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: chelsea gutierrez ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7144010608
• MDR Report Key: 22552662
• Report Number: 3015425075-2025-00203
• Device Sequence Number: 9894434
• Product Code: GZF
• UDI-Device Identifier: 00812537036120
• UDI-Public: (01)00812537036120(11)240229(17)270228
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 71004
• Device Catalogue Number: 71004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown